The present invention relates to a drug adapted to protect individuals against the viral hepatitis infection.
It was only in the early 40""s, in the U.S.A., that viruses (designated. xe2x80x9chepatitis A and hepatitis B virusesxe2x80x9d) capable of causing hepatitis were detected in samples of human blood. Individuals invariably recover from viral hepatitis A, whereas 5-10% of patients affected by viral hepatitis B do not recover, but go on to develop chronic hepatitis or become asymptomatic chronic carriers of the disease. The serum of patients who recover from viral hepatitis infection contains antibodies that neutralize the effect of the virus.
Consequently, in an attempt to protect individuals at-risk of contracting the infection, researchers began first to produce immune serum globulins and later vaccines.
When only hepatitis A and B viruses were known, all viral hepatitis infections not attributable to these viruses were called xe2x80x9cnonA-nonB hepatitisxe2x80x9d. It is important to note that the hepatitis C virus (HCV) was discovered only about seven years ago and that it is the cause of the majority (80%) of parenterally transmitted nonA-nonB hepatitis cases.
Hepatitis C infection can be very severe because of its fatal sequelae, i.e., chronic hepatitis, liver cirrhosis and hepatocellular carcinoma. Only about 20-30% of infected individuals recover from the disease. Furthermore, infected subjects can transmit the infection to other individuals by means of their blood, the sexual route, etc.
It should be noted that most HCV-infected individuals are asymptomatic. Therefore, they are often unaware they have the infection and can transmit it to others.
While vaccines and specific immune preparations are used for the prevention of hepatitis A and B infection, there are at present no measures to protect all the many subjects exposed to the risk of acquiring HCV infection.
At present, HCV affects about 300 million people worldwide. Given the lack of effective protective measures, these infected individuals are a potential danger because they can spread this scourge through the world with devastating human, social and economic consequences.
The drug according to the present invention intends to make available to mankind a product that can effectively protect from HCV infection and is characterized by a substantial hyperimmunity against HCV, said hyperimmunity being due to a substantial hyperconcentration of virus C neutralizing antibodies.
Furthermore the drug according to the invention would be produced from blood units collected from HCV-infected individuals that contain a substantially high concentrations of HCV neutralizing antibodies. The final product would be safe because any HCV or any other possible infectious agents, that could be present in the blood units used for preparing the drug according to the invention, are inactivated by the Cohn method (alcohol fractionation) and/or by other possible virucidal treatments and/or additional methods capable of inactivating infectious agents.
At last, the use of the drug according to the invention is directed to substantially protect the individuals against HCV infection, such as, for example:
sexual partners of HCV-infected patients,
patients undergoing hemodialysis,
patients undergoing dental therapy or chiropodistry,
drug abusers,
patients affected by HCV-related fulminate hepatitis, liver cirrhosis or hepatocellular carcinoma undergoing liver transplantation,
etc, etc.
Additionally, the use of the drug according to the invention is also directed to substantially block HCV infection in all other possible conditions.
These and further features of the drug according to the invention will be apparent from the following description.